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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problems Burn(s) (1757); Burning Sensation (2146)
Event Date 05/16/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4). Date of event: year valid. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for lumbar radiculopathy and spinal pain. It was reported that they started having issues a few months ago, in 2021. Pt was getting no device found and if the number is at 97 or 100 it will not charge and would say try again. Pt was also getting rm03 messages. Also, the day before yesterday ((b)(6) 2021) the pt tried charging and it said 90% on the charger picture but then it said 220% and then back to 90%. Pt reset the controller. Pt said if they shut the controller off and back on, it will come back on but they had to do it 10-20 times in a row to get the device charged. Pt had not gotten a full charge in a few months, only probably a handful of times. Pt also reported the relay box on the recharger got hot to the touch and also the charger got hot. The cord got really hot in the area where it goes into the donut where it actually burned the patient. An email was sent to repair to replace the recharger.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12336007
MDR Text Key267048010
Report Number3004209178-2021-12557
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2019
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/13/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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